Associate Principal Scientist, Microbiology Testing, EM/Utilities Monitoring Program – Onsite/First Shift
Core
Lead the execution of microbiology finished product testing, utilities, and environmental monitoring programs in a GMP laboratory setting to support sterile operations and maintain product integrity.
Role type
Associate Principal Scientist (Microbiology Testing & EM/Utilities Monitoring)
Builds
GMP-compliant microbiology data, contamination control strategies, and inspection-ready monitoring programs for small molecule, biologic, and vaccine products.
Domain
Pharmaceutical manufacturing (GMP), Microbiology, Sterile Processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP microbiology laboratory practices, Environmental Monitoring (EM) program leadership, risk-based assessment, EMPQ, Clean Utilities Monitoring, aseptic process validation, microbiological data review, quality procedures, regulatory compliance, CAPA management, team supervision, project management, statistical evaluation of EM trends, method suitability studies, contamination control strategies.
Preferred skills
Experience with MODA or equivalent systems, SAP, Veeva, LIMS, nonsterile manufacturing testing, internal/external audit processes, contract laboratory oversight.
Technologies
MODA, SAP, Veeva, LIMS
Responsibilities
Lead execution of microbiology finished product testing, utilities, and environmental monitoring; design and justify risk-based EM strategies; oversee EM lifecycle activities including EMPQ and requalification; lead EM data trending and statistical evaluation; identify emerging risks and implement mitigations; execute test method suitability studies; troubleshoot and lead investigations/CAPAs; supervise microbiology team and approve reports; conduct project management of studies at contract laboratories; participate in compliance audits.
Seniority
Senior, hands-on IC with team leadership responsibilities
